First complete dataset in the IL-23p19 class demonstrates ILUMETRI®▼ (tildrakizumab) long term efficacy and safety through 5 years in Patients with Moderate to Severe Psoriasis
BARCELONA, Spain, Oct. 31, 2020 /PRNewswire/ —
- Tildrakizumab is the first anti-IL-23p19 to deliver a full complete dataset analysis demonstrating long-term psoriasis control with a consistent long-term safety profile through 5 years (256 weeks)1
- The data was presented in a late-breaking session at the EADV 29th Congress. In addition, 6 abstracts were accepted, presenting the long-term efficacy and safety of ILUMETRI® in moderate-to-severe plaque psoriasis. PASI and PGA response rates were high and durable in the studies1
- Safety was further explored in different analyses examining incidence rates of severe infections, malignancies, and major adverse cardiovascular events, as well as overall safety in patients over 65 years of age. No new reported signals were found in any of the sub-groups.
Almirall, S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced today that the full 5 year data analysis from two phase III clinical studies, reSURFACE 1 and reSURFACE2 of ILUMETRI® (tildrakizumab), an IL-23p19 inhibitor for the treatment of moderate-to-severe plaque psoriasis, has been presented this Saturday in a late-breaking session at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020.
The late-breaking session and the 6 abstracts presented pooled long term data from reSURFACE 1 and reSURFACE 2, phase III clinical trials showing that, following up to 5 years of treatment with tildrakizumab, PASI and PGA response rates remain high and durable.1 This is the longest complete dataset available on an anti-IL23p19 inhibitor, the most innovative class of drugs for the treatment of moderate-to-severe psoriasis.
"We are delighted and very proud that we are able to be the first anti-IL-23 to disclose a complete dataset of 5-year data on tildrakizumab. This new data demonstrate maintained response rates with a consistent safety profile. We are confident this evidence will help doctors in their clinical decision-making, further adding to our understanding of the role that the IL-23p19 class can play in achieving long-term control." said Dr Volker Koscielny, Chief Medical Officer of Almirall, S.A.
Late-Breaker. Long-term efficacy and safety: up to 5-year results from reSURFACE 11
The results of the 5-year pooled data from reSURFACE 1 and reSURFACE 2 demonstrated long-term control of psoriasis, with maintained efficacy by both relative and absolute PASI, in a large cohort of patients with a total of over 5,400 patient-years exposure to ILUMETRI®. Absolute PASI <3 at week 244 for the tildrakizumab 100mg and 200mg doses were 78.8% and 82.6% respectively. Both the 100mg and 200mg doses were well tolerated with low rates of serious adverse events and adverse events of special interest through 5 years.
"In our study, patients who responded to tildrakizumab maintained a clinically significant response over 5 years. Control of psoriasis was maintained with a reassuring safety profile. This tildrakizumab study confirms the role that the IL23p19 class can play in achieving long term control for our psoriasis patients." stated Prof Diamant Thaçi, Director of the Comprehensive Centre for Inflammation Medicine at Lübeck University in Germany, the first author of the study.
Low rates of malignancies, severe infections and MACE
Safety was further explored in the sub-group analyses examining adverse events of special interests. Low rates of severe infections, malignancies and Major Adverse Cardiovascular Events (MACEs) were reported. No dose dependent increase in events of special interests were observed. There were no new reported signals found in any of the sub-group analysis over 5 years. 2,3,4
Safety in patients 65 years of age or older5
Additionally, long-term data in patients 65 years of age or older was presented. In a pooled analysis after 5 years (256 weeks) of treatment tildrakizumab was well tolerated with low serious adverse events and adverse effects of special interest. No dose related increase in the rate of adverse events were observed.
The 7 abstracts related to the 5 year data are available on the EADV event webpage: https://eadvvirtualcongress.org . Almirall also hosted a Satellite Symposium on the 5-year safety and efficacy of tildrakizumab, and a HUB Session about unmet clinical needs in other dermatology conditions and upcoming treatments.
Tildrakizumab is a humanized monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23) and inhibits the release of proinflammatory cytokines and chemokines with limited impact on the rest of the immune system. Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Tildrakizumab demonstrated superiority vs placebo and etanercept in the phase 3 reSURFACE programme. Significantly more tildrakizumab patients achieved PASI 75 at Week 12 vs. placebo in both studies [re-SURFACE-1/2: 64%/61% (100 mg), 62%/66% (200 mg) vs 6%/6% (PBO), p<0.0001] and vs. etanercept [reSURFACE-2: 61% (100 mg, p=0.001), 66% (200 mg, p<0.0001) vs 48%]. Significantly more tildrakizumab patients achieved a PGA score of 'clear' or 'minimal', with ≥ 2-grade reduction from baseline at Week 12 in both studies vs. placebo [re-SURFACE-1/2: 58%/55% (100 mg), 59%/59% (200 mg) vs 7%/4% (PBO), p<0.0001], TIL 200 mg (59%, p=0.0031) and TIL 100 mg (55%, p=0.0663) vs. ETA (48%). The incidence of severe infections, malignancies, and major adverse cardiovascular events seen in the clinical trials were low and similar across treatment groups, with the most common AE being nasopharyngitis. Tildrakizumab was administered as 100 or 200 mg injection(s) at week 0 and 4 in the induction phase and then every 12 weeks thereafter for maintenance. DLQI 0/1 at week 12 was achieved by 42% of patients (n=309); by week 28 it was achieved by 52% of the patients (n=299) with patients reporting that psoriasis no longer affected their lives. By week 52, 64% of the responders at week 28 achieved DLQI 0/1 (n=113).
Almirall in-licensed Tildrakizumab from Sun Pharmaceutical Industries Ltd. (Sun Pharma) in July 2016. The agreement is for development and commercialization of tildrakizumab in Europe. So far, tildrakizumab has been launched in Germany, United Kingdom, Switzerland, Austria, Denmark, Spain, Italy and France.
- Thaçi D, Piaserico S, Warren R., Gupta A.K., Long-term efficacy and safety of tildrakizumab for moderate to severe psoriasis: pooled analyses of two randomised phase 3 clinical trials (reSURFACE 1 and reSURFACE 2) through 5 years. Presented at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020.
- Lambert J, Gerdes S, Schoenenberger A, Ryzhkova A. Long-term safety profile of tildrakizumab: Incidence of malignancies over 5 years of treatment in patients with moderate-to-severe psoriasis from reSURFACE 1 and reSURFACE 2 phase 3 trials. Presented at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020.
- Pinter A, Lacour J-P, Schoenenberger A, Ryzhkova A. Long-term safety profile of tildrakizumab: Incidence of severe infections over 5 years of treatment in patients with moderate-to-severe psoriasis pooled analyses from reSURFACE 1 and reSURFACE 2 phase 3 trials. Presented at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020.
- Reich K, Ghislain P-D, Schoenenberger A, Ryzhkova A. Long-term safety profile of tildrakizumab: Incidence of confirmed extended major adverse cardiovascular events over 5 years of treatment in patients with moderate-to-severe psoriasis from reSURFACE 1 and reSURFACE 2 phase 3 trials. Presented at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020.
- Van de Kerkhof P, Daudén E, Schoenenberger A, Ryzhkova A. Long-term safety of tildrakizumab in patients over 65 years of age with moderate-to-severe plaque psoriasis: pooled analysis through 5 years (256 weeks) from reSURFACE 1 and reSURFACE 2 phase 3 trials. Presented at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020.
- ILUMETRI® (tildrakizumab) Summary of Product Characteristics.
Universal Sompo General Insurance Company Ltd Launches Upgraded USGI PULZ Mobile Application
MUMBAI, India, Dec. 2, 2020 /PRNewswire/ — Universal Sompo General Insurance Company Limited has launched its mobile application the USGI PULZ. Riding on the wave of digitalisation, the app has been launched with the main intention of enhancing service delivery.
The launch of USGI PULZ application brings Universal Sompo one step closer to its aim of offering a digitally seamless experience to its customers. It is a conscious effort on its part to make the platform more versatile, customer friendly making it a hassle-free experience in terms of faster policy issuance or in terms of claim settlement process. It believes that just with this offering its digital sign-ups will increase by 25-30%.
The USGI PULZ also offers a one stop shop for all post sales insurance needs, online claims intimation, GPS based nearby service providers, marketplace for various value-added services, AI based health risk assessment and lot more. The app offers its customers a feature rich and user-friendly interface.
Unique features of USGI PULZ app include:
About the company
Universal Sompo General Insurance Co. Ltd is a joint venture of Indian Bank, Indian Overseas Bank, Karnataka Bank Ltd, Dabur Investment Corporation and a leading general insurer from Japan, Sompo Japan Insurance Inc.
It has footprints across the country to serve its customers with 17 Zonal Offices, 86 Branch Offices and a 1500 strong workforce. It offers a wide range of products catering to Retail, Rural, SME & Corporate customer segments. It is innovating in the health insurance space and offers both standalone policies and co-branded products in conjunction with its bank partners. It serves customers through a vast and compliant distribution network of banks, agents, brokers, auto dealers, POSPs, CSCs and so on. It continues to invest in technology ensuring smooth purchase experience for customers and rapid integration facility for distributors.
Itiviti plans large scale staff expansion for 2021
LONDON, Dec. 2, 2020 /PRNewswire/ — Itiviti, a leading trading technology and service provider to financial institutions worldwide, today announced a large-scale, multi-year hiring plan to support the company's growth and continued investment into its FX and Fixed Income trading technology across markets in Europe, North America and Asia.
“This hiring plan is a part of our multi-year strategy to deliver innovative and reliable technology that will help our clients achieve sustainable long-term growth,” said Rob MacKay, CEO, of Itiviti. “We grew our team by over 6% in 2020 and we plan to accelerate that growth in 2021.”
Itiviti will be adding more than 200 new research and development (R&D), quality assurance (QA) and client service positions in 2021 and 2022 to keep pace with the firm's ambitious product roadmap. The majority of new staff will be joining the company in its St Petersburg, Cluj and Mumbai offices.
Launching such a large scale investment in staff during this time while other organizations are downsizing is very exciting and promising for us,” said Karoline Raets, Head of People Office, Itiviti. “Throughout the pandemic our flexible work environment has kept employees highly engaged and motivated with no adverse impact on the company's performance. As such, we are very enthusiastic about the career opportunities we can offer going forward for both internal and external talent.”
Continued MacKay: “We made a lot of progress this year to improve our offering in the face of rapidly changing market requirements As trusted providers of trading and connectivity solutions, our commitment to innovation will enable us to deliver on the full potential of our platform no matter where and how our clients choose to operate.”
Visit our newly revamped website and keep up to date on open positions here: itiviti.com/careers.
For further information, please contact:
Mireille Adebiyi, Chief Marketing Officer, Itiviti Group, Email: [email protected]
Itiviti provides nearly 2,000 financial institutions worldwide with flexible, cross-asset trading solutions that cover the full trade lifecycle. Through its commitment to technology innovation, relentless pursuit of workflow efficiency and an entrepreneurial culture, Itiviti is disrupting the industry with highly scalable solutions that deliver unprecedented cost savings for clients.
Itiviti is owned by Nordic Capital.
This information was brought to you by Cision http://news.cision.com
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SOURCE Itiviti Group AB
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Dycom Industries, Inc. – DY
NEW YORK, Dec. 2, 2020 /PRNewswire/ — Pomerantz LLP is investigating claims on behalf of investors of Dycom, Inc. (“Dycom” or the “Company”)(NYSE: DY). Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.
The investigation concerns whether Dycom and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
On November 24, 2020, Dycom announced its financial results for the Company's fiscal quarter ended October 24, 2020. For the quarter, Dycom announced revenue of $810.3 million, missing consensus estimates by approximately $6.64 million and representing a year-over-year decline of approximately 8.3%.
On this news, Dycom's stock price fell $12.52 per share, or 16%, to close at $65.71 per share on November 24, 2020.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
Robert S. Willoughby
888-476-6529 ext. 7980
SOURCE Pomerantz LLP
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